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Expanded Access for CD3+/CD19+ Depleted Stem Cell Transplant

This study offers an expanded access option for patients up to 30 years old with serious conditions like leukemia or bone marrow failure syndromes who need a stem cell transplant (HSCT). It's for those who don't have a fully matched sibling donor and aren't eligible for other studies using the CliniMACs device. The study uses a special process called CD3+/CD19+ depletion with the CliniMACs device. This process removes certain immune cells (T cells) from donor stem cells to reduce the risk of a complication called graft-versus-host disease (GVHD). The main goal is to see how many patients are still alive one year after their transplant. This study aims to help patients who need a stem cell transplant but have limited options.

Study design
This is an interventional study with a planned enrollment of 100 participants. The study is designed to expand access to a specific type of stem cell transplant.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured at 1 year post-transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02356653

Expanded Access Protocol Using CD3+/CD19+ Depleted PBSC

Recruiting
EARLY_PHASE1Up to 30InterventionalTreatment
Children's Hospital of Philadelphia
~100 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Transplant of stem cells with CD3+/CD19+ depletion (CliniMACs)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over 1 year post transplant

Conditions

Leukemia
Inborn Errors of Metabolism
Bone Marrow Failure Syndromes
Immunodeficiencies
Immunodysregulation Polyendocrinopathy Enteropathy X-linked Syndrome

Explore related trials

Bone Marrow Failure SyndromeCongenital Metabolic DisorderHemoglobinopathyImmune Dysregulation, Polyendocrinopathy, and Enteropathy X-Linked SyndromeImmunodeficiencyLeukemiaLymphomaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Timothy Olson, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Megan Atkinson
[email protected]
215-590-2820
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Donor selection will comply with 21 CFR 1271
Unrelated donor that meets the matching criteria of the NMDP with allele matching at HLA -A, -B, -C, -DRB1, and -DQB1: Unrelated donors may be a 10/10 match, a 9/10 match, or an 8/10 match if one of the mismatches is at DQB1
Related donor suitable for mobilization infectious disease criteria as per SOP, including HIV, HepB, HepC PCR negative.
CHOP BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases. Our donor collection program is FACT accredited.
Unrelated donor identified through the National Marrow Donor Program (NMDP) and fulfills the NMDP criteria for donation. Unrelated donor willing and able to undergo mobilization of peripheral stem cells and apheresis.
The donors selected for this IND will either be unrelated donors identified through the National Marrow Donor Program (NMDP) or related donors. Regarding the unrelated donors; NMDP procedures for determining donor eligibility include donor screening and testing for relevant communicable disease agents and diseases

What this trial measures

  • Overall Survival1 year post transplant

    Number of participants who remain alive.